CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
Inosinedrug
Likely dose
Inosine 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02288091
NCT02288091Phase 1Completed
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A Pilot Study of Inosine in Amyotrophic Lateral Sclerosis (ALS)

Massachusetts General Hospital·interventional·Posted Nov 11, 2014·Updated Nov 6, 2017

In Brief

A Phase 1 clinical trial evaluating Inosine for Amyotrophic Lateral Sclerosis. Completed, enrolled 32 participants across 1 site.

Detailed Summary

This is a single center, open label, 12-week study of inosine treatment. Inosine treatment leads to an increase in the levels of urate (uric acid) in the blood. The primary objective of the study is to determine the tolerability of oral administration of inosine. Secondary study objectives include the measurement of biomarkers of oxidative stress and damage in response to inosine treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis
CountriesUnited States
CollaboratorsThe Salah Foundation, Sean M. Healey & AMG Center for ALS

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 11, 2014
Enrollment StartJan 1, 2015
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.6 years ago

Interventions

Inosinedrug

Twenty-five eligible subjects will receive inosine for 12 weeks (administered in the form of 500 mg capsules, 1 to 6 capsules a day for a total daily dose of up to 3 gm). The dose of inosine will be titrated to target urate levels of 7-8 mg/dL based on urate level measurement that will occur at Week 2, Week 4, Week 6, and Week 9 after Baseline.